The present invention provides a method and apparatus for evaluating the margins of a surgically-removed tissue specimen, such as a breast tissue specimen, to determine whether sufficient fatty tissue has been removed from around the lesion or cancerous point. The instant invention provides a solution to the problem of on-site evaluation of the margin sufficiency during the surgical procedure, in that it provides surgeons with an orthogonal view of all sides of the tissue specimen to be evaluated. The specimen evaluation device provides for properly-oriented examination of the removed specimen in a non-compressed, undistorted manner, both by visual inspection and through radiographic evaluation. Through this examination of the properly-oriented specimen, the surgeon may quickly and more accurately be informed of whether there remain cancerous cells in the margins surrounding the sample, which are meant to be free of cancerous cells. Upon evaluation of the margins of the removed sample, the surgeon may then make an on-site determination on whether to proceed with additional surgery or complete the surgical procedure.
When a patient undergoes a surgery to remove a cancerous lump, one of the challenges a surgeon faces is removal of the appropriate amount of tissue from the patient. The surgeon must ensure that sufficient tissue is removed such that the cancerous cells are removed from the body of the patient. Conversely, the surgeon will attempt to make the removal site as contained as possible so as to disturb the body of the patient as little as possible. This may be especially appropriate in the case of breast cancer removal, in which a patient may be particularly sensitive to the removal of large amounts of breast tissue. Additionally, some biopsies are undergone as preventative measures, and a surgeon will be removing tissue samples prior to confirming the presence or absence of cancerous cells. In such a scenario, the surgeon may attempt to remove only a small tissue sample.
Because a surgeon may be attempting removal of a relatively small tissue sample from a patient, evaluation of the tissue sample is required after its removal. Such evaluation may be visual inspection by a surgeon or pathologist, but is more commonly undergone via radiographic evaluation to ensure complete and thorough analysis of the tissue sample. A successful removal of cancerous tissue would include a certain “padding” of cancer-free tissue surrounding the cancerous cells to ensure that the entirety of the cancerous site was removed from the patient. The relative distance away from the edges of the removed sample is referred to as the “margins” of the sample. In a successful removal, such margins would be clear of cancerous cells. If, however, the margins of the removed tissue feature cancerous cells, then the surgeon may have to remove additional tissue from the patient to ensure the cancer was fully removed from the patient. For example, in colloquial terms, a surgeon may remove a tissue sample with a height of five millimeters and width of six millimeters. The surgeon may have previously predicted that the cancerous cells would be contained to the middle section of the removed tissue, such that two millimeters on each of the four edges of the tissue sample are expected to be free of cancerous cells. If, upon evaluation of the removed sample, there remain cancerous cells in any one of these two-millimeter margins, then the surgeon will have to remove an additional section of tissue from the patient. The margins of that sample would then also be evaluated, and once it is determined the margins are clear, then the patient may be confident that the cancerous site was fully removed from his or her body.
It may be appreciated from the above that instances often arise wherein the surgeon has not removed a sufficiently-sized tissue sample, and must conduct a second removal of tissue from the patient. Without the benefit of on-site margin evaluation, the surgeon would not be aware of the need of the second procedure until after the full completion of the first surgery. Thus, the patient would have to undergo an entire second surgical procedure to ensure the full removal of the cancerous site.
Further, in addition to evaluating such tissue margins on-site, it is desirable to provide a complete evaluation of the tissue sample. Some procedures may allow for on-site evaluation of a two-dimensional representation of the tissue sample, such as discussed above. However, a tissue sample, as three-dimensional material, features six sides and its six corresponding margins. Each of these margins must be evaluated to determine whether the margins are clear and the patient's cancer has been sufficiently removed. To fully evaluate all six sides of the sample, in an orthogonal view, the sample itself must be suspended in a non-compressed manner that allows for a fully rotational view of the tissue sample.
However, when a sample is suspended in a manner such that it may be evaluated from every angle, the relative orientation of the sample may be lost in the transition. To fully achieve the objective of on-site, complete evaluation of margin sufficiency, whether by visual inspection or radiographic evaluation, there must be a manner of intuitively orienting the tissue sample such that if one or more of the margins contain cancerous cells, the surgeon will know which area of the patient requires additional tissue removal.
There have been several attempts in the prior art to evaluate a biopsy specimen via a particular type of container or device. However, as outlined below, the prior art has not provided for a container providing a non-compressed, orthogonal view of the tissue sample, which would fully allow the viewer or radiographic instrument to evaluate whether every margin of the removed sample is free from cancerous cells, while at the same time providing a quick and intuitive method of orienting the sample inside the container, which would allow for on-site evaluation of the tissue sample, thereby allowing a surgeon to remove the appropriate amount of tissue from the patient without requiring additional surgery following an off-site evaluation of the sample.
U.S. Pat. No. 5,383,472, issued on Jan. 24, 1995 to Mark T. Devlin et al. for “Method and Apparatus for Handling of Biopsy Tissue Specimen,” discloses a self-contained set of imaging apparatus which permit an excised tissue to be handled, inked, and imaged in radiology and transported to pathology untouched by human hands. Absolute margins of tissue are inked by solution, and injected into sealed, disposable bag from syringe attached to the bag. Inked tissue is removed from bag and placed upon fluid-absorbent Hotter inscribed with radiographically opaque grid, inside of transparent container. Hinged top and bottom panels of liquid-tight container secure tissue in place. Tissue is visible from outside of container during transport, X-ray imaging, and subsequent pathologic evaluation. Further, the image presented to the pathologist with the inked tissue permits extremely accurate identification of locations of suspect element. The pathologist can easily view the enclosed, undisturbed sample and associated radiograph prior to dissection, which can be done with said apparatus if so desired.
U.S. Application Publication No. 2005/0112758, published May 26, 2005 by Meaghan Archambault et al. for “Method and Apparatus for the Storage of a Tissue Specimen,” discloses a device that is provided for transporting a tissue specimen without the risk of exposing health-care workers to potentially hazardous tissue fluids. The device includes a container, a flexible portion, a first support member, a first locating indicia on a first side of the first supporting member, and a second substantially radiopaque locating indicia on a second side of the first support member, and an indicating member movably mounted on the first side of the first support member. The first support member has a first locating indicia on a first surface and a second locating indicia on a second surface, which generates a radiographic image when exposed to X-rays. The first and second indicia are substantially in registration such that when a tissue specimen is positioned on the first locating indicia and is then exposed to X-rays, a radiographic image of the specimen superimposed on the image of the second locating indicia is produced. Since both locating indicia are in registration, any tissue abnormality within the specimen can be precisely located with respect to both indicia. The device further includes a second support member, limiting contact of the container walls with the tissue specimen, and biasing the flexible portion away from the first support surface containing the tissue specimen. The device further includes an at least partially radiopaque indicating member for indicating the position of the tissue specimen on the radiographic image. A method for using the device to generate radiographic images of a tissue specimen is also disclosed.
U.S. Pat. No. 5,609,827, issued on Mar. 11, 1997 to Donald G. Russel et al. for “Biopsy Specimen Container,” discloses a container that has a bottom surface and an outer wall extending from the bottom surface. A sheet of absorbent material lines the bottom surface. A container cover engages with the outer wall. The cover, wall, and bottom define an internal chamber. A divider is mounted within the chamber to form a central compartment and a plurality of peripheral compartments. Radiographically, readable indicia identify each compartment.
U.S. Pat. No. 6,238,907, issued on May 29, 2001 to Doris Schuler-Maloney et al. for “Container for Storing and Examining Placentas,” discloses a container for examination and storage of a placenta that includes a bottom wall, at least one substantially upright side wall joined to the bottom wall to define an interior and an open top. The side walls and/or the bottom wall have indicia thereon adapted to measure the size of the placenta in three dimensions. Indicia are also provided to measure the umbilical cord. The container is stackable for storage, and labeling areas are provided. A basic method of examining a placenta is disclosed, along with further steps and variations.
U.S. Pat. No. 4,131,998, issued on Jan. 29, 1979 to Cohn P. Spears for “Tumor Growth Measurement Device,” discloses a device for measuring growth of tumors, and includes concentric rings on a carrier, the radial spacing of the rings from one another progressively increasing in a radially outward direction. The invention relates generally to the measurement of tumor growth, and more particularly to a simple indicator which may be placed over a tumor to measure growth rate.
It may be appreciated from the foregoing that there is a need in the art for a method and apparatus that provides for appropriate evaluation of a removed tissue sample, for determination of whether the margins are sufficiently clear of cancerous cells.
It is therefore an object of the present invention to provide for an apparatus that displays a 360-degree view of a tissue specimen to the observer.
It is a further object of the present invention that said 360-degree view is provided with 90-degree indicators, such that the observer may evaluate the location of cancerous cells in an intuitive, orthogonal orientation.
It is a further object of the present invention to provide an apparatus that may hold the tissue specimen in a non-compressed manner so that the specimen is undistorted during evaluation.
It is a further object of the present invention to provide an apparatus that is simple to enact and easy to transport, allowing for the quick and intuitive on-site observation of the removed tissue sample, and further ensuring the integrity of the orientation of the sample when it is transported for radiographic evaluation, which in turn may give a surgeon the opportunity to remove additional tissue as needed prior to completion of the initial surgery.